KWTClass II
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
21 CFR 888.3650 / Orthopedic
KWT is the FDA product code for Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a class II device type, regulated under 21 CFR 888.3650. As of , FDA records hold 71 510(k) clearances under this code, the most recent dated , and 31 recalls.
Classification record
- Product code
- KWT
- Device name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Regulation
- 21 CFR 888.3650
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 72
- Ingested recalls
- 31
Clearances, product code KWT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1983 | 3 |
| 1987 | 4 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 3 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 5 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 5 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2007 | 1 |
| 2010 | 1 |
| 2011 | 5 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Applicants with the most clearances
Product code KWT| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 19 |
| CATALYST ORTHOSCIENCE Inc | 5 |
| Intermedics Orthopedics | 5 |
| Exactech, Inc. | 4 |
| Kirschner Medical Corp. | 4 |
| Biomet Orthopedics, Inc. | 3 |
| Depuy, Inc. | 3 |
| implantcast GmbH | 3 |
| Fx Shoulder Solutions SAS | 2 |
| Howmedica Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.